Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see Pages 1-2, filed 11/21/2025, with respect to the rejection(s) of claims 1, 14, 16, 19-20 and 23-27 under Bains (WO 2020061584 A1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Docherty et al. (AU 2020205272 A1).
The teachings of Docherty read to the amended limitations of claim 1 of claimed invention of a lyophilized rapidly infusing composition comprising cannabidiol, gelatin and a sugar alcohol. The teachings of Docherty in view of the prior arts of Bains (WO 2020061584 A1), Ridall et al. (US 20180369221 A1), Williams (US Patent No. 20200061138), Hallow et al. (WO 2020051371 A1), Donaduzzi et al. (WO 2019153064 A1), Rosenbaum et al. (US Patent No. 20190307675) and Bastos et al. (WO 2020171727 A2) reads to claims 3-28 of claimed invention.
Applicant has canceled claim 2, claims 1 and 3-28 is now pending. Claims 1 and 3-28 is now evaluated on its merits.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 9, 14, 16 and 20-27 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Docherty et al. (AU 2020205272 A1).
Regarding claims 1, 9, 14, 16 and 20-27, Docherty teaches a method of treating condition and diseases selected from a group consisting of Alzheimer's disease or Parkinson's disease (relevant to claims 23-24, 26) (para. 0085) comprising administration a lyophilized composition of a lipophilic active agent (para. 0026) of cannabidiol (CBD) or a derivative or an analog thereof (relevant to claim 14) (para. 0005, 0015, 0075) and excipients selected from a group consisting of mannitol (relevant to claim 9) (para. 0078) and bioavailability enhancing agent of gelatin (para. 0065-0066).
Of the above composition Docherty teaches administration via orally buccal, sublingual, transmucosal, intravenous, or intestinal administration (relevant to claims 1 and 20) (para. 0075) and the composition further comprising a flavoring agent (relevant to claim 16) (para. 0081). Docherty additionally teaches the CBD in the amount of 0.1 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg or 5 mg (relevant to claim 21-22) (para. 0073) and the composition having additionally cannabinoid compounds selected from THC, CBG, CBC or CBCV (relevant to claim 27) (para.0039).
In terms of the limitations of symptoms of claim 25, Docherty teaches treating Alzheimer’s disease, wherein the condition of long-term memory loss is known in the art to be a well-known symptom of Alzheimer’s disease.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Docherty et al. (AU 2020205272 A1) in view of Bains (WO 2020061584 A1).
The teachings of Docherty for the above 102 rejections of claims 1, 9, 14, 16 and 20-26 are incorporated herein by reference.
Docherty additionally teaches the composition comprising a CBD taste masking agent. Docherty fails to teach the composition with a sweetener of sucralose and acesulfame-K.
Bains teaches methods for treating a disorder selected from Parkinson's disease, Alzheimer's disease, Alzheimer's dementia, Autism Spectrum Disorder, and seizures comprising administering a therapeutically effective amount of a cannabis extract of CBD or a derivative or analog thereof and/or THC and a glycerin-gelatin combination by way of rapidly infusing sublingual oral mucosa (para. 0054, 0059, 00289, claim 99)
Bain additionally teaches the composition further comprising a sweetener or flavoring agents (para. 0046) of acesulfame potassium and Sucralose (relevant to claim 19) (para. 00110, 00155) as well as other active ingredients (para. 0042) by route of buccal mucosa (para. 0061).
Therefore, it would have been obvious by someone of ordinary skill in the art at the time of filling to have administered the composition taught by Docherty to treat Alzheimer's disease wherein the composition comprised sweeteners of acesulfame potassium and Sucralose. One would have been motivated to do so from the teaching of Docherty of a CBD taste masking agent as well as the teachings of Bains of the same active ingredients by the same route of administration to treat the same condition of Alzheimer's disease comprising additional sweetener of acesulfame potassium and Sucralose. There is a reasonable expectation of treating Alzheimer's disease by the composition taught by Docherty wherein the composition additionally comprises sweeteners of acesulfame potassium and Sucralose to mask the taste of CBD. It is also known in the art taste making with different sweeteners is routine experimentation.
Claims 3-8 are rejected under 35 U.S.C. 103 as being unpatentable over Docherty et al. (AU 2020205272 A1) in view of Ridall et al. (US 20180369221 A1).
The teachings of Docherty for the above 102 rejections of claims 1, 9, 14, 16 and 20-26 are incorporated herein by reference.
Docherty fails to teach the composition having a disintegration time of approximately 1 to 30 seconds in deionized water maintained at 37° C ± 2° C, bovine gelatin in an amount of 10 to 35 wt% and mannitol in an amount of 5 to 35 wt%.
Ridall teaches a lyophilized DSI composition comprising pharmaceutical ingredients of bovine gelatin, water, mannitol, a flavorant, a surfactant and an active pharmaceutical ingredient for the mucosal cavity of an animal. The composition has a disintegration time of 7 seconds or less in deionized water maintained at 37.0° C ± 0.5° C and the composition is placed into a mucosal cavity of an animal to be treated with the active pharmaceutical ingredient and to the corresponding methods of treatment (relevant to claims 3-4 and 6-7) (abstract, para. 0051). Ridall additionally teaches gelatin having 10-17 wt% dry mass and 10-17 wt% dry mass of mannitol (relevant to claims 5 and 8) (claim 1).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filling to have developed the CBD composition taught by Docherty with the limitations of the composition comprising bovine gelatin in an amount of 10 to 35 wt%, mannitol in an amount of 5 to 35 wt% and disintegration time of approximately 1 to 30 seconds in deionized water maintained at 37° C ± 2° C to treat Alzheimer’s disease. One would been motivated to do so from the teachings of Ridall of a lyophilized composition administered in the mucosal cavity with ingredients of gelatin and mannitol that falls within the above limitations. The invention of Docherty and Ridall are of the same ingredients of lyophilized composition comprising gelatin and mannitol administered into mucosal cavity. Thus, there is a reasonable expectation of administering the composition taught by Docherty with limitations of the composition comprising bovine gelatin in an amount of 10 to 35 wt%, mannitol in an amount of 5 to 35 wt% and disintegration time of approximately 1 to 30 seconds in deionized water maintained at 37° C ± 2° C to treat Alzheimer’s disease.
Claims 10-12 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Docherty et al. (AU 2020205272 A1) in view of Williams (US Patent No. 20200061138).
The teachings of Docherty for the above 102 rejections of claims 1, 9, 14, 16 and 20-26 are incorporated herein by reference.
Docherty fails to teach the CBD in an amount of 20 to 70 wt%, as a solid form of CBD, CBD with purity between 95 to 99.9 wt% and second therapeutic agent selected from the list of agents of claim 28.
Williams teaches cannabinoid compounds for the treatment of Alzheimer's disease, and particularly to prevent the development of social recognition deficit in subjects when administered in the early stages of Alzheimer's disease comprising solid CBD in an amount of .10 to 50 dry wt%, having purity between 95% to 99.9% (relevant to claims 10-12) (para. 0016, 0034, 0044). Williams additionally teaches the CBD in a range of about 0.1 to about 5 mg/kg/day and addition of a second therapeutic of a non-steroidal anti-inflammatory drug (relevant to claim 28) (para. 0060, 0062).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filling to have administered the CBD composition taught by Docherty; wherein the CBD is solid having purity between 95% to 99% in an amount of 20 to 70 dry wt% and administered with an additional therapeutic agent of a non-steroidal anti-inflammatory drug. One would have been motivated to do so from the teachings Williams and Docherty of CBD and an additional therapeutic agent to treat Alzheimer’s disease, wherein the CBD is in a range of .01 and 5 mg. There is a reasonable expectation of success using the teachings of Williams in the solid high purity CBD amount and therapeutic agent of a non-steroidal anti-inflammatory drug to the composition taught by Docherty to treat Alzheimer’s disease.
Claims 13, 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Docherty et al. (AU 2020205272 A1) in view of Hallow et al. (WO 2020051371 A1), Donaduzzi et al. (WO 2019153064 A1) and Rosenbaum et al. (US Patent No. 20190307675).
The teachings of Docherty for the above 102 rejections of claims 1, 9, 14, 16 and 20-26 are incorporated herein by reference.
Docherty fails teach the CBD in solid form that has been micronized to have a D50 diameter between 1 and 50 µm, the CBD derivative being cannabidiolic acid methyl ester and wherein the flavorant comprises lemon-lime flavor.
Hallow teaches solid form CBD for the treatment of Alzheimer's disease and Parkinson’s disease (para. 00185), wherein the CBD has a D50 diameter between 8 µm and 40 µm (relevant to claim 13) (claim 46).
Donaduzzi teaches pharmaceutical composition containing synthetic cannabidiol of cannabidiolic acid methyl ester to treat various neurological disorders of which includes Parkinson's disease and Alzheimer's disease (relevant to claim 15) (abstract, para. 0015, 0094).
Rosenbaum teaches oral delivery of cannabidiol, which include sweeteners and flavorants of lemon-lime (relevant to claim 17) (para. 0009, 0037).
Therefore it would have been obvious to someone of ordinary skill in the art at the time of filling to have administered the CBD composition taught by Docherty in which the CBD derivative is cannabidiolic acid methyl ester, with a D50 diameter between 1 and 50 µm and a flavorant of lemon-lime. One would have been motivated to do so from the teachings of Hallow and Donaduzzi on cannabidiolic acid methyl ester and CBD having a D50 diameter between 1 and 50 µm administered to treat neurological diseases of Parkinson's disease and Alzheimer's disease along with lemon-lime flavorant being well known in the art to be a flavorant associated with CBD. There is a reasonable expectation of success with treating neurological diseases of Parkinson's disease and Alzheimer's disease by the composition of Docherty in which the CBD is cannabidiolic acid methyl ester having a have a D50 diameter between 1 and 50 µm and flavorant of lemon-lime.
Claims 18 is rejected under 35 U.S.C. 103 as being unpatentable over Docherty et al. (AU 2020205272 A1) in view of Bastos et al. (WO 2020171727 A2).
The teachings of Docherty for the above 102 rejections of claims 1, 9, 14, 16 and 20-26 are incorporated herein by reference.
Docherty fails to teach the composition with colorant of FD&C Yellow #5.
Bastos teaches compositions of mucosal delivery sublingually or buccally agents for treating diseases of Alzheimer’s and Parkinson’s comprising colorant FD&C Yellow #5 (para. 00034, 000196). Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filling to have used the colorant FD&C Yellow #5 to the CBD composition of Docherty to treat neurological diseases of Alzheimer’s and Parkinson’s. One would have been motivated to do so from the teachings of Bastos of FD&C Yellow #5 being a known colorant used in mucosal delivery administration to treat neurological diseases of Alzheimer’s and Parkinson’s.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627